Class II recallOngoing

Dexcom G7 recall: two unauthorized sensor lots

FDA · FDA event 98968 · Posted Jun 24, 2026

Published Jun 24, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

On 05/26-27/2026, the firm issued a Press Release and sent an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" informing customers and the public that Dexcom is aware that two lots (1725204004 and 1725069002) of Dexcom G7 sensors, originally designated as scrap and intended for destruction, were stolen and distributed.
For Patients/Healthcare Providers: 1. Check lot number on G7 sensor outer box and compare with the listed lot numbers in this notification. If the lot number is listed, the device is affected. If affected, skip to step 3 below to document affected serial number(s). 2. Determine if current or unused sensor(s) is affected based on serial number by visiting www.dexcom.com/theft-check and enter serial number into the serial number look-up. Reference https://www.dexcom.com/faqs/how-to-find-dexcom-g7-serial-number for instructions. 3. If you have affected product(s), immediately discontinue use and dispose of them. Contact Dexcom Technical Support at 1-844-478-1600 with questions or to request a no-cost replacement. Important: Keep record of affected serial number for traceability purposes This is required to confirm no cost replacement. 4. Replace the affected sensor with an unaffected sensor for glucose monitoring. If you do not have an unaffected G7 sensor, use a blood glucose meter for treatment decisions until you receive a replacement sensor. 5. Contact healthcare provider if you have symptoms of infection or inflammation redness, swelling, or pain at the insertion site.
Independent Pharmacies: Check inventory if purchased G7 sensors from Pharmsource, LLC. If you have product from the lots listed, immediately dispose of the product. Contact Dexcom with any related inquiries at inquiries@dexcom.com.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references Dexcom G7 Continuous Glucose Monitoring System by Dexcom, Inc..

Products affected by FDA event 98968
Model	Description	Lot / serial range	Manufactured	Status
Z-2574-2026 · STP-AT-012 · N/A	Dexcom G7 US Retail Sensor/Transmitter 1-pack	Lot Code: UDI-DI: 00386270004109 Lot Numbers: 1725204004 and 1725069002	Not provided in the normalized record	Ongoing

Distribution: Dexcom does not have distribution records for this product due to its unauthorized release. However Dexcom is able to identify sensor session starts for the affected lots through the Dexcom G7 CGM App user performance data. Based on App user performance data, Lot 1725204004 has sensor session starts in the United States. Based on App user performance data, Lot 1725069002 has sensor session starts in the United States and the countries of Australia, Austria, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, South Korea, Kuwait, Netherlands, Poland, Portugal, Qatar, Singapore, Spain, Switzerland, Turkey, United Arab Emirates,and the United Kingdom.
Units affected: See official FDA record
Category: Continuous glucose monitors

Timeline

May 27, 2026
Recall initiated
Date recorded by the FDA.
Jun 24, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 98968
Published: Jun 24, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

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Dexcom G7 recall: two unauthorized sensor lots

FDA · FDA event 98968 · Posted Jun 24, 2026

Published Jun 24, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 98968
Model	Description	Lot / serial range	Manufactured	Status
Z-2574-2026 · STP-AT-012 · N/A	Dexcom G7 US Retail Sensor/Transmitter 1-pack	Lot Code: UDI-DI: 00386270004109 Lot Numbers: 1725204004 and 1725069002	Not provided in the normalized record	Ongoing

Distribution

Dexcom does not have distribution records for this product due to its unauthorized release. However Dexcom is able to identify sensor session starts for the affected lots through the Dexcom G7 CGM App user performance data. Based on App user performance data, Lot 1725204004 has sensor session starts in the United States. Based on App user performance data, Lot 1725069002 has sensor session starts in the United States and the countries of Australia, Austria, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, South Korea, Kuwait, Netherlands, Poland, Portugal, Qatar, Singapore, Spain, Switzerland, Turkey, United Arab Emirates,and the United Kingdom.

Units affected

See official FDA record

Dexcom G7 recall: two unauthorized sensor lots

Follow Dexcom G7 Continuous Glucose Monitoring System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Dexcom G7 recall: two unauthorized sensor lots

Follow Dexcom G7 Continuous Glucose Monitoring System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline